Field of the Invention
The present invention is directed to a specimen collection container and, more particularly, a specimen collection container having two chambers separated by a valve for separating a patient's initially voided urine from the mid-stream portion of the urine sample.
Description of Related Art
When obtaining a urine sample for an ambulatory patient, it is generally preferable to collect the sample from the midstream portion of the urine stream. It is important to reject the “first-burst” urine from samples because the first volumes of voided urine carry a disproportionately higher level of bacteria. Bacteria is often picked up from external skin/tissue and also possibly from the urethral volume. The elevated bacteria level of the first stream or first-burst urine can lead to false-positive results for presence of bacteria, and could falsely suggest urinary tract infection, leading to unnecessary treatment or medication and inappropriate patient management. Since surface bacteria are always present, the chance for contamination of a urine sample is universal. As a result, urine samples are typically requested as “clean catch” or “mid-stream”. Such requests require the patient or a care provider to use antiseptic wipes to disinfect external tissue. Additionally, patients are instructed to allow the first urine to fall into the toilet before filling a sample collection cup. It is believed that the first-burst urine not only contains elevated bacteria from the tissue surface, but in fact “washes” the external surfaces, such that there is little or no errant surface bacteria captured in later midstream urine volumes.
The state-of-the-art for midstream urine collection is essentially a manual process which relies entirely on the user or patient to perform the collection correctly. Typical instructions for midstream urine collection may require a user to void into the toilet, then stop urine flow, move the collection cup into position, void into the cup until it is full, stop the urine flow and move the filled cup away, and finish voiding into the toilet. Generally a user will be instructed to clean the surrounding external tissue/skin with an antiseptic wipe before voiding. The process is messy, with a user's hands being near the urine stream and often exposing the user's skin to urine.
Messiness and discomfort are not the only drawbacks from having a manual user-dependent process. In addition, patients need to be given adequate instructions placing an additional requirement and burden on both patient and caregiver. Often, such as in situations where privacy is impossible (e.g., in the midst of a busy emergency room setting), caregivers do not provide any instructions at all. In addition, patients may not understand or choose not to follow the instructions even when they are given, particularly if the patient is already nervous, scared, or agitated. For example, there is significant anecdotal evidence of people not using the antiseptic wipes, either because they burn or are uncomfortable or because patients mistake the antiseptic wipes for hand wipes to be used after providing the sample. Indeed, there is no way to know, short of actually watching the patient provide the urine sample, whether any of the instructions are actually followed.
There are also physiological complications that may contribute to elevated bacterial contamination. Some evidence indicates that intentionally interrupting the urine flow can lead to the reintroduction of bacteria, essentially creating a new “first-burst” of urine from the reinitiated urine flow. The reinitiated urine may not flow over the same skin/tissue as the first flow, and, as a result, may pick up bacteria from previously un-wetted skin. Another possibility is that the ceased urine flow may actually dislodge bacteria, dead cells, or other potential contaminants that would not have been available to contaminate urine during an otherwise normal voiding event. Thus, the manual start-stop-start again process for collecting midstream urine may itself contribute to some bacterial contamination.
The frequency of bacterial contamination of urine samples ranges from 10-40%, depending on the nature of the tests and the institution where the studies are performed. Such statistics indicate that the problem is widespread and quite common. It likely contributes to significant waste, both in increased cost and time associated with handling poor samples or running tests that give ambiguous or potentially useless data. Retesting may be appropriate in some circumstances; however, especially in outpatient settings, the patient may not be available to provide a second sample. Consequently, a re-test is either never performed or simply never requested.
Therefore, in view of the difficulties in obtaining a correct urine sample using currently available methods, there is a need for a collection apparatus which makes the collection process easier and reduces the risk of exposing the patient to the urine flow. The apparatus should be intuitive to use and should be designed to promote proper use and handling of the collected sample at all points before, during, and after voiding of urine. Further, the device should increase patient comfort and convenience by effectively selecting the midstream urine, so the user does not need to consciously force stop-then-start voiding. Not requiring the patient to start-stop-start voiding urine flow reduces the risk of natural physiologic contamination from stream interruption. Similarly, the device should require only minimal manipulation by a patient in order to collect the urine. Furthermore, the apparatus should eliminate the need for patients to be directly exposed to the urine stream. Finally, to ensure safe and easy transfer of the urine sample from the collection container to a specimen collection tube for testing, the device should include one or more access ports permitting direct flow of the collected sample from the container to a test tube.